Code | 2451D | ||||||||||
MA number | 59/0481/16-S | ||||||||||
Product Form: | sol inj 10x20 ml (liek.inj.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Baxalta Innovations GmbH, Austria | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 28.11.2016 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Cuvitru 200 mg_ml_03.2024.pdf |
PIL: | PIL_Cuvitru 200 mg_ml_03.2024.pdf |
Safety feature | Yes |
Data update: | 07.01.2022 |